Učinak liječenja relapsno-remitentne multiple skleroze interferonom beta-1b: rezultati trogodišnje studije praćenja

The aim of this prospective study was to evaluate therapeutic effects in a cohort of 32 patients with relapsing-remitting multiple sclerosis (RRMS) that were continuously treated with interferon beta-1b during a three-year period and to compare the results obtained with literature data available. Additionally, dropouts and side effects were assessed. The annual relapse rate at three years of treatment as the primary study end-point decreased by 60.5% compared with the relapse rate throughout the pretherapeutic course of disease (0.39±0.55 vs. 0.97±0.46; P<0.001) and by 71.3% compared with the relapse rate one year prior to treatment (0.39±0.55 vs. 1.34±0.65; P<0.001). The mean Extended Disability Status Scale (EDSS) increased significantly from 2.46±0.86 at baseline to 2.90±1.30 (P<0.01) at three years of treatment, whereas the mean progression index (EDSS/disease duration) decreased significantly from 0.76±0.50 prior to treatment to 0.43±0.24 (P <0.001), yielding a 56.6% improvement and proving the disease modifying effect of interferon beta-1b. Seventeen (53.12%) patients remained relapse-free during the course of therapy. Among patients that experienced disease relapse, the mean time to first exacerbation was 11.5±8.34 months. Our study results were consistent with similar studies performed worldwide, clearly indicating that Interferon beta-1b therapy decreased the disease activity and had a beneficial effect on the progression of RRMS, with low incidence and severity of serious side effects. This study has paved way for further long-term follow up studies at our institution.Cilj ove prospektivne studije bio je procijeniti učinkovitost terapije interferonom beta-1b u grupi od 32 bolesnika oboljela od relapsno-remitentne forme multiple skleroze liječenih tokom trogodišnjeg perioda, te dobivene rezultate usporediti sa rezultatima dostupnim u literaturi. Pacijenti kod kojih je iz različitih razloga obustavljena terapija također su detaljno obrađeni. Primarni pokazatelj, godišnja stopa egzacerbacije nakon tri godine terapije, pokazala je statistički značajan pad za 60,5% u odnosu na stopu egzacerbacije tokom cijelog trajanja bolesti (sa 0,97±0,46 na 0,39±0,55), odnosno za 71,3% u odnosu na godinu prije započinjanja terapije (sa 1,34±0.65 na 0,39±0,55; P<0,001). Prosječna vrijednost EDSS se značajno povećala od 2,46±0,86 prije započinjanja terapije do prosječnih 2,90±1,30 (P<0,01), ali je srednji indeks progresije bolesti (EDSS/ duljina trajanja bolesti) bio značajno niži nakon tri godine terapije (0,43±0,24) u odnosu na indeks progresije tokom cjelokupnog trajanja bolesti (0,76±0,50; P